Pharmacovigilance (PV) Regulatory Officer

Location: Zagreb, HR

PrimeVigilance is continuing to expand and is looking for a PV Regulatory Officer to join our dynamic and rapidly growing organization.

PV Regulatory Officer has primary responsibility to ensure that the PV Regulatory Department responsibilities and activities (Regulatory Intelligence, XEVMPD, EV/FAERS registration activities) are managed in a cost efficient manner of the highest quality and in compliance with global regulations and company policies and in accordance with any PV agreement.

PV Regulatory Officer has a senior position responsible to ensure that all contracted PV Regulatory Department responsibilities and activities are managed in compliance with regulations and company policies and in accordance with any PV agreement. The role includes review and implementation of efficiency strategies whilst maintaining the highest quality of work.

Key Accountabilities
  • Performing Regulatory Intelligence activities
  • Managing and of Quality checking Core RRRT Tables
  • Performing and Quality checking weekly/monthly regulatory review
  • Providing pharmacovigilance and vigilance regulatory intelligence advice to PrimeVigilance clients and employees
  • Ensuring all information requiring submission to the XEVMPD is sent by the client, requesting any missing information and monitoring compliance
  • Performing data entry for XEVMPD of all initial entries and regular updates, including MedDRA coding
  • Performing quality check for XEVMPD of all initial entries and regular updates, including MedDRA coding
  • Overviewing the client specific XEVMPD data
  • Performing testing of the system and registration with EudraVigilance (EV), Food and Drug Adverse Event Reporting System (FAERS) and the National Competent Authorities
  • Performing Trusted Deputy function for EV/FAERS
  • Maintaining EV/FAERS accounts
  • Performing quality check of all ICSRs submission to Regulatory Authorities, Ethics Committees (EC)/Institutional Review Boards (IRB) and Investigators and exchange of ICSRs with clients or client’s partners, as appropriate
  • Reviewing and signing Submission Cover Letter for paper reporting
  • Providing support in managing the team responsible for ICSRs and aggregate report submissions to the regulatory bodies worldwide, including safety reporting from clinical trials and exchange of ICSRs with clients or client’s partners
  • Developing PV training presentations and delivering PV training as required
  • Maintaining up-to-date knowledge of regional and national regulations, guidelines and advisory documents for post-marketing, clinical trials and medical device reporting
  • Assisting with developing and improving pharmacovigilance regulatory processes and procedures, as required
  • Mentoring and training of new and more junior employees within the department
  • Participating in Inspections and Audits

Qualifications and Skills
  • University degree in Biomedical sciences or Natural sciences
  • Advanced knowledge of English
  • Advanced knowledge of MS Word and Excel
  • Excellent attention to detail and organizational skills
  • Independent problem solving and decision-making skills
  • Process oriented and critical thinking
  • Responsible approach to work duties

Our Offer
  • Competitive salary
  • Dynamic team of colleagues in a fast-growing company – possibility for your quick career growth
  • Multicultural environment, English as a company language
  • Strong emphasis on personal and professional growth
  • Extensive and specialized trainings in pharmacovigilance – internal trainings provided by skilled professionals, but also prestigious trainings/seminars taking place abroad
  • Friendly working environment with several social events per year

If you would like to be considered for this opportunity, please send your application via email to enclosing your English CV and Cover Letter.

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Thank you for your application. Unfortunately, because of the volume of applications we receive, we are not able to give status updates, but if you are invited for an interview, we will contact you directly.

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